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• W4387255145 abstract "SESSION TITLE: New Diagnostic Tools and Treatments in OSA in Adults and Children SESSION TYPE: Original Investigations PRESENTED ON: 10/08/2023 09:30 am - 10:30 am PURPOSE: Currently, FDA guidance for obstructive sleep apnea (OSA) treatment by oral appliances is only for patients with mild or moderate OSA severity. This study evaluated severe OSA patients treated with novel mRNA and DNA appliances (Vivos Therapeutics, Littleton, CO). These appliances are designed to be worn 6-24 months, and use slow maxillary expansion (DNA) combined with mandibular advancement (mRNA) to increase upper airway volume and improve OSA. METHODS: This retrospective analysis used a research database initiated in 2018 incorporating real world data from treating dentists through 12/2021 for mRNA and through 4/2022 for DNA. The database contains pre- and posttreatment (without the oral appliance) AHI, transpalatal width (TPW) and airway volume (AV) via cone beam computed tomography (CBCT), and safety data. Study inclusion criteria were adults with severe OSA (AHI > 30), mRNA/DNA treatment, pre- and posttreatment AHI > 6 months apart, and appliance adherence ≥ 10 hours/day; exclusion criteria were adjunct OSA treatments and no safety data. Co-primary endpoints were pre- to posttreatment AHI and TPW improvement, and secondary endpoints were pre- to posttreatment AV improvement and safety measures. RESULTS: As per sample size estimation, 39 patients with severe OSA (17 mRNA and 22 DNA) were contrasted with 35 patients with moderate OSA (12 mRNA and 23 DNA). Severe OSA: 20 men / 19 women, Age 56.9±11.5 years, BMI Pre- / Posttreatment 30.0±5.8 / 30.7±8.0, Treatment Duration 14.8±6.6 months, Appliance Adherence 12.4±2.6 hours. Moderate OSA: 15 men / 20 women, Age 48.9±11.7 years, BMI Pre- / Posttreatment 25.0±4.2 / 25.0±4.6, Treatment Duration 12.3±6.7 months, Appliance Adherence 12.4±2.5 hours. For severe OSA patients, pre-treatment vs. posttreatment AHI, TPW, and AV were found to significantly decrease 46.2±17.3 to 22.5±14.3 (-50.1%, p<.00001), increase 33.6±3.1 to 35.8±3.4 mm (+7.1%, p<.00001), and increase 21170±9374 to 24497±10424 mm3 (+22.4%, p<.00001), respectively. For moderate OSA patients, pre-treatment vs. posttreatment AHI, TPW, and AV were found to significantly decrease 21.6±4.5 to 12.0±10.5 (-44.4%, p<.00001), increase 32.9±2.8 to 35.1±2.9 mm (+6.6%, p<.00001), and increase 21598±6260 to 24364±6033 mm3 (+12.8%, p<.005), respectively. Severe OSA patients who wore mRNA and DNA appliances decreased their AHI by 49.2% and 52.8%, respectively, and moderate OSA patients who wore mRNA and DNA appliances decreased their AHI by 38.5% and 47.6%, respectively. No significant safety issues were observed. CONCLUSIONS: Use of novel oral appliance treatment for patients diagnosed with severe OSA was as safe and effective as for those with moderate OSA, and patients with severe OSA patients showed more improvement in AHI, TPW, and AV vs. those with moderate OSA. Patients with DNA (expansion only) performed slightly better than patients with mRNA in these measures, indicating that the primary improvement mechanism is maxillary expansion. CLINICAL IMPLICATIONS: Oral appliances historically have treated only mild-moderate OSA patients. This study shows that severe OSA can be improved with oral appliances, and importantly the DNA and mRNA appliances are an advancement over conventional oral appliances since they modify the upper airway predominantly via maxillary expansion so that treatment effects persist without the appliances in place. DISCLOSURES: No disclosure on file for Jonathan Alexander Consultant relationship with Vivos Therapeutics Please note: 2019-present Added 04/13/2023 by Colette Cozean, source=Web Response, value=Consulting fee Scientific Medical Advisor relationship with Vivos Therapeutics Please note: 8/18/2020- present Added 03/25/2023 by Clete Kushida, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Cerebra Health Please note: 1/15/2021-present Added 03/29/2023 by Clete Kushida, source=Web Response, value=Consulting fee Consultant relationship with M^3 Public Benefit Corporation Please note: 11/17/2020-present Added 03/29/2023 by Clete Kushida, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Restful Robotics Please note: 5/3/2021-present Added 03/29/2023 by Clete Kushida, source=Web Response, value=Consulting fee Consultant relationship with Koko Home Inc. Please note: 10/11/2021-present Added 03/29/2023 by Clete Kushida, source=Web Response, value=Consulting fee Consultant relationship with Asleep Please note: 11/1/2022-present Added 03/29/2023 by Clete Kushida, source=Web Response, value=Consulting fee" @default.
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• W4387255145 date "2023-10-01" @default.
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• W4387255145 title "TREATMENT OF SEVERE OBSTRUCTIVE SLEEP APNEA BY NOVEL ORAL APPLIANCES" @default.
• W4387255145 doi "https://doi.org/10.1016/j.chest.2023.07.4047" @default.
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